ETODOLAC

Product NDC
61919-251
11-digit product format
619190251
Labeler code
61919
Product ID
61919-251_f2027140-5922-5c24-e053-2a95a90adfe5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ETODOLAC
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
DIRECT RX
Application
ANDA076004
Marketing category
ANDA
Marketing start
2016-08-29
Marketing end
0000-00-00
Substance
ETODOLAC
Active strength
400 mg/1
Pharmacologic classes
Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
No
Listing certified through
2024-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bb9faa76-10d1-4b5f-ab9b-d6a26495edb7Product name120250311
0c3d95a8-02c3-425e-810b-2a14408d9a06Product name420250218
24aa5265-325f-0e21-8836-2c9a907c0454Product name220210601

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61919-251-302025-01-30C16284748780-12cef2736-789f-d83d-e063-dadaa90ab31fETODOLAC
61919-251-602025-01-30C16284748780-12cef2736-789f-d83d-e063-dadaa90ab31fETODOLAC

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-251-30ETODOLAC30 in 1 BOTTLETABLET, FILM COATED305
61919-251-60ETODOLAC60 in 1 BOTTLETABLET, FILM COATED605

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-251-30EA - Each61919-2514b201e99-f954-4b95-b6c5-afe26a827b3f12019-11-12
61919-251-60EA - Each61919-251e1a31ffb-afad-4601-90f4-12b6425e5fe912019-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-251ETODOLAC TABLET, FILM COATED [DIRECT RX]5Legacy NDC, 2 package rows20230418_3b3610c8-b937-41a4-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197686etodolac 400 MG Oral TabletPSN3b3610c8-b937-41a4-e054-00144ff88e885
197686etodolac 400 MG Oral TabletSCD3b3610c8-b937-41a4-e054-00144ff88e885

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
61919-251-306191902513030 TABLET, FILM COATED in 1 BOTTLE (61919-251-30) 2016-08-290000-00-00NoNoCurrent
61919-251-606191902516060 TABLET, FILM COATED in 1 BOTTLE (61919-251-60) 2016-08-290000-00-00NoNoCurrent